An extension study of FK506 (Tacrolimus) ointment as a follow-up to the double-blind comparison study in children with atopic dermatitis
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Accession number;05A0310802
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| Title;An extension study of FK506 (Tacrolimus) ointment as a follow-up to the double-blind comparison study in children with atopic dermatitis |
| Author;
OTSUKI MAMITARO
(Dep. Medicine, Jichi Medicial School, JPN)
KAWASHIMA MAKOTO
(School of Medicine, Tokyo Women's Medical Univ., JPN)
HARADA SHOTARO
(Nippon Telegraph and Telephone East Corp., Kanto Medical Center, JPN)
NAKAGAWA HIDEMI
(Dep. Medicine, Jichi Medicial School, JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.21;NO.3;PAGE.335-360(2005)
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| Figure&Table&Reference;FIG.6, TBL.21, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A double-blind vehicle-ointment-controlled comparison study of FK506 ointment in children with atopic dermatitis was conducted from 2000 to 2001. Upon completion of this study, a number of subjects who were judged as needing to continue treatment with the same drug had a desire to do so. With the participation of these pediatric patients, an extension study was conducted until July 2003 to evaluate the safety and efficacy of FK506 ointment with long-term use. 1) All 134 of the registered patients were judged as eligible for the present study and thereupon included in the safety and efficacy analyses. Duration of treatment (ointment application) and patient observation were 668.9 days on average, with a median of 792 days. More than half the patients underwent treatment and observation for 2 years or longer, up to 1,060 days (2 years 11 months). 2) The starting concentration of the ointment was 0.03 %. If there was insufficient efficacy after 4 weeks of treatment, then use of the 0.1 % ointment was permitted, but only 17 patients (12.7 %) received the 0.1 % ointment while many patients were able to control symptoms with the 0.03 % ointment alone. 3) Adverse drug reactions for which causality with the investigational product could not be ruled out included skin irritation, infection and other accompanying symptoms in areas where the ointment was applied in 55 patients (41.0 %), 55 patients (41.0 %), and 15 patients (11.2%), respectively. Similarly, infection and other accompanying symptoms in areas other than those treated with the ointment were observed in 11 patients (8.2 %) and 1 patient (0.7 %), respectively. The nature of these adverse drug reactions was not significantly different from those observed in the long-term study (1 year).... (author abst.) |
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